FDA panel backs vedolizumab for UC, Crohn's

FDA's Gastrointestinal Drugs and Drug Safety and Risk Management advisory committees were unfazed by FDA reviewers' concerns about the potential risk of progressive multifocal leukoencephalopathy (PML) with Entyvio vedolizumab from the Millennium Pharmaceuticals Inc. subsidiary of Takeda Pharmaceutical Co. Ltd. (Tokyo:4502). The panel members unanimously voted that Takeda adequately characterized the risk of PML with vedolizumab, which is under review to treat ulcerative colitis (UC) and Crohn's disease (see BioCentury Extra, Dec. 5).

Of the 21 panel members, 13 voted that the benefits of vedolizumab outweigh the potential risks for UC in patients that have failed steroids, immunosuppressants or anti- TNF alpha therapy, while eight voted that the benefits outweigh the risks for patients who failed immunosuppressants or anti-TNF alpha therapy but not steroids. For the Crohn's indication, 14 panel members voted that the benefits of vedolizumab outweigh the potential risks for patients who have failed steroids, immunosuppressants or anti-TNF alpha therapy, while six voted the benefits outweigh the risks for patients who have failed immunosuppressants or anti-TNF alpha therapy but not steroids. One panel member voted that the benefits did not outweigh the risks for either population of Crohn's disease patients. ...